Acquired Brain InjuryBRAINReADAPTNCT05499806
Cohort Study on the Effects of Aging in Acquired Brain Injury Patients
An observational study of Acquired Brain Injury and Subarachnoid Hemorrhage, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
A prospective cohort study (questionnaires), with an embedded case control study (neuropsychological assessments) in which the data is gathered within a timeframe of 3 years. A group of 700 patients and a group of 100 healthy volunteers will be participating. Read more about this study
- Who is it for?
- Ages 50 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury, Subarachnoid Hemorrhage, Traumatic Brain Injury
- How many people
- 800 participants
- Where
- 2 sitesNetherlands
- Study dates
- 18 Mar 2022to 1 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have suffered an acute ABI defined by a traumatic brain injury, stroke or subarachnoid haemorrhage who have been admitted at the UMCG or one of the other participating centers.
Who may be able to join
- Current age range between 50-67 years [Rationale: having an age that enables the patient to experience the effects of aging with a low risk of neurodegenerative disease]
- Able to complete questionnaires independently
- Additionally, patients must also meet the following criteria:
- Age of acquiring the ABI ≧ 25 years [Rationale: the brain is supposed to be fully developed at a maximum capacity
- ABI must be ≧ 5 years ago] [Rationale :time period regarded sufficient to have achieved a stable level of cognitive functioning and participation after an ABI]
- ABI diagnosis at hospital admission with abnormalities at the brain-CT or MRI
- Independent regarding Activities of Daily Living
- Not living in a long-term care facility
Who cannot join
- Psychiatric disease (for which participant is currently treated)
- Accompanying disease with reduced life expectancy
- Neurological disease (including recurrent ABI for patients)
- Language barriers prohibiting and completion of Dutch questionnaires
- Alcohol or drug abuse
- Suspected neurodegenerative disease
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Revalidatiecentrum Heliomare Wijk aan Zee
Wijk aan Zee
Isala klinieken
Zwolle, Overijssel, 8025 AB
About this study
A prospective cohort study (questionnaires), with an embedded case control study (neuropsychological assessments) in which the data is gathered within a timeframe of 3 years. A group of 700 patients and a group of 100 healthy volunteers will be participating.
Read the detailed description
In the Netherlands an estimated 650.000 people live with the daily consequences of an Acquired Brain Injury (ABI). A substantial amount of these patients acquired their brain injury (traumatic brain injury, subarachnoid hemorrhage or cerebrovascular accident) at a relatively young age: between 18 and 50 years old. The chain-of-care for ABI aims for recovery in the subacute phase, usually within a period of one year after injury. After an adaptation period, the patients reach a new balance, with stabilization of complaints and reintegration, sometimes with the necessity of modifications. The group of patients who acquired a brain injury at a young age, have to face the effects of aging like decreased cognitive functions, which can cause the participation level to drop. This is called the ABI-effect in the current study. At this moment, insufficient information is available about the functioning of people who suffered ABI multiple years ago and have established a new balance, and now make the transition to an older phase of live.
Primary objective:
Explore the prevalence of the ABI-effect, by mapping the participation level.
Secondary objective:
Substantiate the occurence of the ABI-effect, by mapping cognitive functions of patients and compare these to healthy controls.
Tertiary objective:
Gain insight in the need of care for patients, to enhance regular care after ABI.
- Conditions
- Acquired Brain Injury, Subarachnoid Hemorrhage, Traumatic Brain Injury, Cerebrovascular Accident
- Medical subject headings
- Brain Injuries, Subarachnoid Hemorrhage, Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acquired Brain Injury Patients | Questionnaire and, if the requirements are met, a neuropsychological assessment. | |
| Healthy volunteers | Questionnaire and, if the requirements are met, a neuropsychological assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the ABI-effect
The percentage of patients experiencing the ABI-effect. Also, a 95% confidence interval of this prevalence will be calculated.
Measured: A minimum of 5 years after ABI
Secondary outcomes (1)
Cognitive functions of patients and healthy volunteers
The significant difference in cognitive functions between the patient groep and the healthy controls
Measured: A minimum of 5 years after ABI for patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start18 Mar 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Joukje van der Naalt, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499806
- Sponsor's protocol ID
- NL79072.042.21
- Acronym
- BRAINReADAPT
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on the Effects of Aging in Acquired Brain Injury Patients
- ClinicalTrials.gov ID
- NCT05499806
- Acronym / sponsor ID
- BRAINReADAPT / NL79072.042.21
- Conditions
- Acquired Brain Injury, Subarachnoid Hemorrhage, Traumatic Brain Injury, Cerebrovascular Accident
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective cohort study (questionnaires), with an embedded case control study (neuropsychological assessments) in which the data is gathered within a timeframe of 3 years. A group of 700 patients and a group of 100 healthy volunteers will be participating.
Detailed description
In the Netherlands an estimated 650.000 people live with the daily consequences of an Acquired Brain Injury (ABI). A substantial amount of these patients acquired their brain injury (traumatic brain injury, subarachnoid hemorrhage or cerebrovascular accident) at a relatively young age: between 18 and 50 years old. The chain-of-care for ABI aims for recovery in the subacute phase, usually within a period of one year after injury. After an adaptation period, the patients reach a new balance, with stabilization of complaints and reintegration, sometimes with the necessity of modifications. The group of patients who acquired a brain injury at a young age, have to face the effects of aging like decreased cognitive functions, which can cause the participation level to drop. This is called the ABI-effect in the current study. At this moment, insufficient information is available about the functioning of people who suffered ABI multiple years ago and have established a new balance, and now make the transition to an older phase of live.
Primary objective:
Explore the prevalence of the ABI-effect, by mapping the participation level.
Secondary objective:
Substantiate the occurence of the ABI-effect, by mapping cognitive functions of patients and compare these to healthy controls.
Tertiary objective:
Gain insight in the need of care for patients, to enhance regular care after ABI.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acquired Brain Injury Patients | – | –Questionnaire and, if the requirements are met, a neuropsychological assessment. |
| Healthy volunteers | – | –Questionnaire and, if the requirements are met, a neuropsychological assessment. |
Who may qualify
- Ages
- 50 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have suffered an acute ABI defined by a traumatic brain injury, stroke or subarachnoid haemorrhage who have been admitted at the UMCG or one of the other participating centers.
Key inclusion criteria (8 listed)
- Current age range between 50-67 years [Rationale: having an age that enables the patient to experience the effects of aging with a low risk of neurodegenerative disease]
- Able to complete questionnaires independently
- Age of acquiring the ABI ≧ 25 years [Rationale: the brain is supposed to be fully developed at a maximum capacity
- ABI must be ≧ 5 years ago] [Rationale :time period regarded sufficient to have achieved a stable level of cognitive functioning and participation after an ABI]
- ABI diagnosis at hospital admission with abnormalities at the brain-CT or MRI
Key exclusion criteria (6 listed)
- Psychiatric disease (for which participant is currently treated)
- Accompanying disease with reduced life expectancy
- Neurological disease (including recurrent ABI for patients)
- Language barriers prohibiting and completion of Dutch questionnaires
- Alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of the ABI-effect
Time frame: A minimum of 5 years after ABI
The percentage of patients experiencing the ABI-effect. Also, a 95% confidence interval of this prevalence will be calculated.
1 secondary outcome
Cognitive functions of patients and healthy volunteers
Time frame: A minimum of 5 years after ABI for patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Brain Injury and Subarachnoid Hemorrhage, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the ABI-effect (time frame: A minimum of 5 years after ABI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.